UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of aflibercept in wet age-related macular degenaration (wAMD) with retinal pigment epithelium detachment (PED)
Title of the study (Brief title)	Effect of aflibercept in wAMD with PED
Region	Japan

Condition
Condition	exudative age related macular degeneration
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of aflibercept on visual acuity and retinal morphology in AMD with PED
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Ratio of patients with improved/maintained BCVA at month 12 2) Ratio of patients with PED regression
Key secondary outcomes	Change of BCVA, PED, central macular thickness, polyp lesion, etc.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	aflibercept
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Willingness to provide written informed consent 2) wAMD with CNV on FA, ICGA, OCT 3) PED (>1 disc diameter) on OCT 4) Treatment na&iuml;ve 5) BCVA > 0.1 (decimal score)
Key exclusion criteria	1) Drusenoid PED 2) Avascular PED 3) GLD of the total lesion area > 12 4) Presence of RPE tears or macular hole 5) Subretinal hemorrhage, scar or macular fibrosis (>50% lesion area) 5) History of Triamcinolone (< 6 months), dexamethasone (< 30 days), intraocular surgery (< 6 months) 6) Vitrectomy, submacular surgery, etc. 7) Active intraocular inflammation 8) Hypersensitivity or allergy to fluorescein, indocyanine green, etc. 9) Pregnancy, lactating woman
Target sample size	50

Research contact person
Name of lead principal investigator	Kanji Takahashi
Organization	Kansai Medical University
Division name	Department of Ophthalmology
Address	Shinmachi 2-5-1, Hirakata
TEL	072-804-0101
Email	nagaiy@hirakata.kmu.ac.jp

Public contact
Name of contact person	Yoshimi Nagai
Organization	Kansai Medical University
Division name	Department of Ophthalmology
Address	Shinmachi 2-5-1, Hirakata
TEL	072-804-0101
Homepage URL
Email	nagaiy@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

Funding Source
Organization	Bayer Yakuhin Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	関西医科大学附属病院、関西医科大学附属滝井病院、大阪大学医学部附属病院、住友病院

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 25 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 07 Month 11 Day
Anticipated trial start date	2013 Year 08 Month 01 Day
Last follow-up date	2015 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 07 Month 25 Day
Last modified on	2018 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013212